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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 13 Results
ProductCode: GEI Applicant: GYRUS ACMI, INC. Decision Date To: 12/01/2022
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olympus pk electrosurgical instruments, pk j-hook, pk spatula, pk needle Gyrus ACMI, Inc. K213831 01/04/2022
pk morcellator GYRUS ACMI, INC. K161038 10/07/2016
pk cutting forceps for esg-400 workstation GYRUS ACMI, INC. K142759 01/13/2015
pk needle GYRUS ACMI, INC. K142154 12/19/2014
olympus energy power system (eps) GYRUS ACMI, INC. K123429 04/05/2013
gyrus amci pk button electrode GYRUS ACMI, INC. K120567 06/20/2012
pk superpulse sysem generator model 744000 GYRUS ACMI, INC. K100816 07/01/2010
gyrus acmi halo pks cutting forceps GYRUS ACMI, INC. K100896 06/17/2010
g3 generator and accessories-dissector plasma knife GYRUS ACMI, INC. K080844 08/13/2009
pk diego powered dissector console, model 7033-9050, diego trigger-enabled powered dissector handpiece, model 7033-9001 GYRUS ACMI, INC. K083013 12/09/2008